Diabetes Mellitus, Type 1 Clinical Trial
Official title:
International Report on Routine Practice of Sensor-enabled Pump Therapy
NCT number | NCT00790088 |
Other study ID # | EUR04 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2009 |
Est. completion date | May 2012 |
Verified date | October 2018 |
Source | Medtronic Diabetes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the project is to document the international routine practice in sensor usage in patients treated with sensor-augmented pump therapy and to assess which variables (e.g. training of patients, frequency of sensor usage etc) are associated with an improvement in clinical outcome(s) from the start of the sensor use to the end of the follow-up period.
Status | Completed |
Enrollment | 274 |
Est. completion date | May 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patient (and/or legal representative) has signed Patient Informed Consent (PIC) - Patient was diagnosed with Type 1 DM and has been on insulin infusion pump therapy (without any additional insulin injection) for at least 6 months prior to signature of the PIC - The treating physician decided independently of the study to prescribe non-blinded continuous glucose monitoring as part of the patient's pump therapy for at least 10% of the study time (estimated as days per month) Exclusion Criteria: - Participation in any other clinical trial - currently and/or in the last 3 months prior to signature of informed consent - Patient has preliminary experience with non-blinded continuous glucose monitoring prior to signature of informed consent (not naïve to non-blinded continuous glucose monitoring) - For children: no reliable contact person |
Country | Name | City | State |
---|---|---|---|
Austria | LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I | Salzburg | |
Belgium | Universitair Ziekenhuis Antwerpen | Antwerpen | |
Belgium | AZ Imelda | Bonheiden | |
Denmark | Fredericia Hospital | Fredericia | |
Denmark | Hvidovre Hospital | Hvidovre | |
France | Hôpital de Dax | Dax | |
France | Centre Hospitalier de Haguenau | Haguenau | |
France | Centre Hospitalier La Rochelle | La Rochelle | |
Hungary | Réthy Pál Hospital | Békéscsaba | |
Hungary | Péterfy Hospital, Outpatient Clinic | Budapest | |
Hungary | Josa András Teaching Hospital | Nyiregyhaza | |
Israel | Chaim Sheba Medical center | Tel Hashomer, Ramat Gan | |
Italy | Sacco Hospital, University of Milan | Milan | |
Italy | Ospedale S. Camillo Forlanini | Roma | |
Lithuania | Kaunas University Hospital | Kaunas | |
Poland | Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp | Bialystok | |
Poland | Specjalistyczna Praktyka Lekarska | Gliwice | |
Poland | Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz | Krakow | |
Serbia | Clinical Center of Serbia | Belgrade | |
Slovakia | TopCare s.r.o. | Kosice | |
Slovakia | National Institute of Endocrinology | Lubochna | |
Slovenia | University Childrens Hospital | Ljubjana | |
Spain | Hospital Universitario Infanta Cristina | Badajoz | |
Spain | Complejo Hosp. Santiago De Compostela | Santiago de Compostela | |
Spain | Hospital Virgen del Rocio | Sevilla | |
Sweden | Astrid Lindgrens Barnsjukhus | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Medtronic Diabetes |
Austria, Belgium, Denmark, France, Hungary, Israel, Italy, Lithuania, Poland, Serbia, Slovakia, Slovenia, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency as Percentage of Sensor Usage | To calculate the percentage of time that sensors were used during 3 months: the total number of recorded sensor readings during 3 months was divided by the theoretical number of sensor readings that would be observed if sensor was worn every day of using pump to deliver insulin during the same period (ie, observed readings / (theoretical 288 readings per day x nber of days with insulin use)) and multiplied by 100 |
every 3 months | |
Primary | HbA1c | every 3 months | ||
Primary | Percentage of Patients Achieving HbA1c < 7% | every 3 months | ||
Primary | Percentage of Patients Achieving HbA1c < 7.5% | every 3 months | ||
Secondary | Fear of Hypoglycemia Survey (HFS-II) - Total Score and Behavior Score | sub-group of patients (adults only in Hungary and Denmark) were asked to answer the fear of hypoglycemia validated questionnaires. The total HFS-II questionnaire is represented by 33 items. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always.The total HFS-II score ranges from 0 to 132. Lower score at 6 months or 12 months compared to baseline represents a better outcome. The HFS-II questionnaire is divided into 2 subscales: the behavior and the worry subscales. The behavior score is represented by 15 items and ranges from 0 to 60. Lower score at 6 months or 12 months compared to baseline represents a better outcome. |
at baseline, after 6 and after 12 months | |
Secondary | Fear of Hypoglycemia Survey (HFS-II) - Worry Score | sub-group of patients (adults only) were asked to answer the fear of hypoglycemia validated questionnaires. The respondents rank the responses on a 5- point Likert scale where zero is never and four is always. The worry subscale is the mean of 18 items which evaluate the worry score (range from 0 to 72). Lower score at 6 months or 12 months compared to baseline represents a better outcome. | at baseline, after 6 and after 12 months | |
Secondary | Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) | A sub-group of patients (adults) were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs) The treatment satisfaction is measured by means of the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 6 to 0. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month or 12 months compared to baseline represents a better outcome. Items 2 (perceived frequency of hyperglycaemia) and 3 (perceived frequency of hypoglycaemia) are treated individually in data analysis. Lower score at 6 months or 12 months compared to baseline represents a better outcome. | at baseline, after 3 and after 12 months |
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